510(k) K770082

Device

SALONMAY BUSTLINE INCREASER

Applicant

Gamma Enterprises, Inc.

510(k) number

K770082

Product code

MWZ

Decision

Substantially Equivalent (SESE)

Decision date

1977-03-16

Date received

1977-01-14

Regulation

890.5660

Classification name

Expander, Breast, External

Medical specialty

Physical Medicine

Review panel

Physical Medicine

Device class

1

Clearance type

Traditional

Third party reviewed

N